Status:
COMPLETED
Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-70 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (\< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents
- Body mass index between 26 and 40 kg/m2
- HbA1c between 7.5% and 10.0%
- Fasting plasma glucose \>7.8 mmol/L and fasting C-peptide \> or =0.25 nmol/L
Exclusion
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2001
Estimated Enrollment :
764 Patients enrolled
Trial Details
Trial ID
NCT00653341
Start Date
January 1 2000
End Date
October 1 2001
Last Update
April 20 2009
Active Locations (2)
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1
Sanofi-aventis administrative office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-aventis administrative office
Laval, Canada